drugset / Trial / NCT01974609
Narcotic vs. Non-narcotic Pain Study Protocol
Phase 4
Completed
347 enrolled
Horizon Health Network
Carilion Clinic · collabJefferson Medical College of Thomas Jefferson University · collabLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · collabMcGill University · collabSanford Health · collabUniversity of Michigan · collabUniversity of Western Ontario, Canada · collab
RandomizedParallel-groupQuadruple-blindSupportive care
Summary
The purposes of this noninferiority randomized clinical trial are to: 1. determine whether the most commonly used commonly used non-narcotic analgesic (ibuprofen 600 mg + acetaminophen 325 mg) provides pain relief that is not unacceptably worse than the most commonly prescribed narcotic containing analgesic (hydrocodone 5 mg. + acetaminophen 325 mg, equivalent to Norco 5/325) in patients undergoing carpal tunnel release. 2. Determine whether the following covariates affect pain level following surgery or medication usage: gender, country (US/Canada), pre-operative CTS symptoms, site, workers compensation status and employment status (employed/self-employed/unemployed-able to work/unemployed-unable to work)
Timeline
- Start
- 2016-03
- Primary completion
- 2022-02-24
- Completion
- 2022-02-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 325 mg | — |
| Subject | Hydrocodone | Unknown | 5 mg | — |
| Subject | Ibuprofen | Small molecule | 600 mg | — |